A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults.
Status:
Completed
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
The purpose of the study is to learn about:
- The activity of sisunotavir in the body over a period. It includes the processes by
which sisunotavir is absorbed, distributed in the body, localized in the tissues, and
removed from the body.
- safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult
participants.
This information is being collected to support further clinical development as well as
medicine registration in China.
This study is seeking for participants who:
- are male and female participants aged 18 to 65 years of age.
- are male and female participants who are healthy as seen by medical tests.
- have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50
kilograms (110 pounds).
About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200
milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be
followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4
to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day
with a meal.
The total time of participants will be in the study is about 71 days. This includes the
screening visit to the Follow-up contact. In screening visit, participants will be tested to
see if they are fit to take part in the study.